2541g Food Process Filing for Low-Acid Aseptic Systems

Form Approved: OMB NO. 0910-0037; Expiration Date 10/31/2023 (See PRA Statement on last page)

Food Process Filing for Low-Acid Aseptic Systems
(Form FDA 2541g)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Note: There are separate process filing forms for each of the following: Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d); Food Process Filing for Acidified Method
(Form FDA 2541e); Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f); and Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g).
USE FDA INSTRUCTIONS ENTITLED “Instructions for Paper Submission of Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems)”
FDA USE ONLY

Date Received by FDA:

/

/

(MM/DD/YYYY)

Food Canning Establishment (FCE) Number (Enter number assigned by FDA)

Submission Identifier (SID) (YYYY-MM-DD/SSS)

20
A. Product Information

Mixed Vegetables (e.g., carrots and peas, etc.)
Mixed Vegetables as a Juice or Drink (e.g., carrot and green bean juice, etc.)

Baby Food (infant/junior foods including infant formula)

Nut Spread and Nut Topping

Bakery Products (canned brown bread, bakery glazes)

Other Vegetables

Rice, Wheat, Oat or Grain (liquid form – ready-to-eat such as grits)

Berry/Citrus/Core Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping

Root and Tuber Vegetables

Breakfast Foods (liquid form – ready-to-eat, such as porridge, gruel)

Root/Tuber Vegetables (e.g., carrots, leeks, potatoes, etc.)

Cheese (does not include soy cheese or imitation dairy)
Coffee/Teas (excluding herbal and botanical teas)

/

Mixed Vegetables

1. (Optional) Select one Food Product Group. If there is no single best Food Product
Group that applies, select Other.

Cocoa

-

A.1 (Food Product Group) (Continued)

Note: Section A.1 (Food Product Group) requests optional information.

Beverage Base

-

Root/Tuber Vegetables as a Juice or Drink (e.g., carrot juice, etc.)

Dairy (milk-based)

Dietary Supplement and/or herbal and botanical teas

Soup

Dressings/Condiments (e.g., salad dressing, chutney, salsa, pepper sauce, etc.)

Sweet Goods/Dessert (liquid form – ready-to-eat, such as pudding)

Vine/Other Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping
Wine Cooler

Fruit as a Vegetable

Other (Specify below)

Fruit as a Vegetable (e.g., eggplant, pumpkin, etc.)
Fruit as a Vegetable Juice or Drink (e.g., eggplant juice, pumpkin juice, etc.)
Gelatin, Pudding Filling for Pies, Pie Filling (liquid form ready-to-eat such as apple pie
filling, etc.)

2. Enter Product Name (e.g., Cheese Sauce (with Jalapeno Pieces), Pudding (Vanilla or
Strawberry), etc.).

Gravies/Sauces (spaghetti sauce, mushroom gravy)
Imitation Dairy (includes soy-based products)
Imitation/Pit/Mixed/Subtropical Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping

3. What is the form of the product? (Select all that are applicable)
Liquid (i.e., all liquid no solids)

Leafy/Stem Vegetables
Leafy/Stem Vegetable

Paste/Puree

Leafy/Stem Vegetable as a Juice or Drink (e.g., spinach juice, etc.)

Other (Enter product form)

Liquid with Solids (e.g., diced, chunks, pieces, etc.)

Meal Replacement/Medical Foods (e.g., supplemental liquid nutrition, etc.)

FORM FDA 2541g (12/20)

Page 1 of 8

PSC Publishing Services (301) 443-6740

EF

Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g)
C. Container Type (Continued)

A. Product Information (Continued)
4. What is the packing medium? (Select all that are applicable)
Brine

Cream/Sauce/Gravy

Oil

Syrup

Water

2.

None

Flexible Pouch
a) What is the shape of the container? (Select one)

Other (Enter packing medium)

Flat pouch

Gable top

Gable top/side gusseted

Gusseted

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Continue to Section B.

B. Governing Regulation (Refer to the precursor questions in the
instructions)

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

x Low-acid (21 CFR 108.35 and 21 CFR Part 113)
3.

Continue to Section C.

Semi-Rigid
a) What is the shape of the container? (Select one)

C. Container Type (Select one)

Bowl

Note: If the product is not packaged in one of the container types identified below,
select Other.
1.

Cylindrical

Oval

Rectangular

Tray

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Aluminum/Tinplate/Steel Can
a) What is the shape of the container? (Select one)
Cylindrical

Oval

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Rectangular

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

b) Is this a single piece container?

c) Is this a compartmentalized container?
Yes

b) How many pieces are used to construct the container? (Select one or more choices,
as applicable)
i.
2-pieces
ii.

3-pieces

How many compartments? _ _

No

d) What is the predominant material used to make the body of the container? (Select one)
HDPE (high-density polyethylene)
Paperboard

HDPP (high-density polypropylene)

PET (polyethylene teraphthalate)

Other (Enter material)

How is the side seam sealed? (Select one)
Cemented

No (Continue to c)

Yes (Continue to d)

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Welded

Note: If “Yes” is selected as a single piece container in question 3.b, continue
to Section D.

FORM FDA 2541g (12/20)

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Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g)
C. Container Type: 3. Semi-Rigid (Continued)

D. Container Size

HDPP (high-density polypropylene)

Nylon

Note: Section D.1 (dimensions) is required information; however, volume is
acceptable for container size in lieu of container dimensions if package sterilizer
does not depend on the container dimensions. Section D.3 (net weight) is optional
information.

PET (polyethylene teraphthalate)

Not Applicable

1. Dimensions:

e) What is the predominant material used to make the lid of the container? (Select one)
Aluminum/Steel

HDPE (high-density polyethylene)

Other (Enter material)

a) _ _ _ _ Diameter _ _ _ _ Height (Use for cylindrical shapes) (see accompanying
instructions for proper coding)
b) _ _ _ _ Length _ _ _ _ Width _ _ _ _ Height/Thickness (Use retangular shapes,
pouches, or irregular shapes) (see accompanying instructions for proper coding)

f) How is the lid sealed to the body of the container? (Select one)
Heat Seal

Double Seam
Press Twist

Snap On

Ultrasonic Seal

Induction Weld

2. Volume: _ _ _._ (Select one)

Threaded Closure

Fluid Ounces

Not Applicable

Gallons

Liters

Milliliters

3. Net Weight (Optional): _ _ _._ _ (enter in ounces)

Other (Enter seal type)

Continue to Section E.
4.

Other (Enter container type)

E. Product Processing Method: Thermally Processed using Aseptic Systems
Product Sterilization

a) Attach schematic or picture of container. (Provide name or a brief description of
attachment below.)

a) What is the finished equilibrium pH of the product after processing? _ _._ _
b) Heating Method
i. (Select one)

b) Specify the material that, based on weight, is the predominant material used to make the
container stock. This is the material that constitutes the highest weight value of the
container stock.
c) Specify the predominant material used to make the lid. This is the material that
constitutes the highest weight value of the lid stock. If the container does not have a lid,
specify Not Applicable.
d) Specify the method used to seal the lid to the body of the container. If the container does
not have a lid, specify Not Applicable.

Direct Heating

Indirect Heating

ii. What is the Thermal Expansion Coefficient? _._ _
iii. Where is the product flow rate controlled? (Select one)
Before the heater (Continue to b.iii.1)
(1) Volume Expansion Factor: _._ _

After the heater (Continue to c)

(Direct Heating Only)

c) What is the Manufacturer's name and the model number of the Product Sterilization
System?

d) What is the Process Source of the Product Sterilization System?
(Attach Process Source Document. Provide name or a brief description of
attachment below.)

Continue to Section D.

e) What is the date of the Process Source Document of the Product Sterilization System
(mm/dd/yyyy)? _ _ / _ _ / _ _ _ _

Continue to Section F.
FORM FDA 2541g (12/20)

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Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g)

F. Product Critical Factors: (Complete all product critical factor questions
as delineated by process authority to assure commercial sterility.)

F. Product Critical Factors (Continued)
6. Answer the following questions if the flow correction factor you identified in question F.5 is
0.83 (Turbulent)
a) What is the instrument used to measure the consistency/viscosity?

1. Does the product contain particulates?
Yes

b) What is the temperature when you measure the consistency/viscosity? _ _ _._

(Attach supporting documentation and validation reports. Provide name or a brief
description of attachment below.)

(enter in Fahrenheit)
c) What is the consistency/viscosity?

What is the unit of measure? (Select one)

(Continue to a)

Centipoise

Other (Enter the units of measure)

No (Continue to F.2)
a) Is controlling particulate size a critical factor?
Yes (Continue to b)

_ _ _._ _ _

d) What is the specific gravity? _._ _ _ _

No (Continue to F.2)

b) What is the shape and dimension of the particulate size to be controlled? If more than
one, list all that apply.

7. Is starch added to maintain consistency/viscosity of the product?
Yes (Continue to a-b)

No (Continue to F.8)

a) What is the maximum % starch added? _ _._ _
b) What type of starch is added?

2. Does the product contain any dry ingredients that are hydrated before processing the product?
Yes (Continue to a)

No (Continue to F.3)

a) What is the minimum % moisture of the hydrated dry
ingredients before processing? _ _._ _

Not Applicable

8. Are other binders added?
Yes (Continue to a-b)

3. Does the % total solids affect the heating of the product during processing?
Yes (Continue to a)
a) What is the % total solids?

a) What is the maximum % binder?

_ _._ _
9. Is syrup strength a critical factor that needs to be controlled during processing?
Yes (Continue to a)

No

5. What is the flow correction factor used during the scheduled process? (Select one)
a)

0.5 (Laminar) (Continue to Section G)

b)

0.83 (Turbulent) (Continue to F.6)

FORM FDA 2541g (12/20)

_ _._ _

b) What is the type of binder added?

No (Continue to F.4)

4. Is the finished equilibrium pH of the product after processing (identified in Section E) critical
to the process?
Yes

No (Continue to F.9)

a) What is the brix measurement?

Continue to Section G.

Page 4 of 8

No (Continue to Section G)
_ _._

Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g)

G. Package Sterilization System and Supplemental Information

G. Package Sterilization System and Supplemental Information: 3. Sterilization
System (Continued)

1. Sterilization System

c) What is the date of the Process Source of the Package Sterilization System
(mm/dd/yyyy) _ _ / _ _ / _ _ _ _

a) What is the Manufacturer name and the model number of the sterilization system used
to sterilize the packaging of the product?

d) Supplemental Submission Identifier (SUP SID) _ _ _ _ - _ _ - _ _ - _ _ _
b) What is the Process Source of the Package Sterilization System?

(Attach Supplemental Information. Provide name or a brief description of
attachment below.) (See accompanying instructions.)

c) What is the date of the Process Source of the Package Sterilization System
(mm/dd/yyyy) _ _ / _ _ / _ _ _ _

4. Sterilization System

d) Supplemental Submission Identifier (SUP SID) _ _ _ _ - _ _ - _ _ - _ _ _

a) What is the Manufacturer name and the model number of the sterilization system used
to sterilize the packaging of the product?

(Attach Supplemental Information. Provide name or a brief description of
attachment below.) (See accompanying instructions.)

b) What is the Process Source of the Package Sterilization System?
2. Sterilization System
a) What is the Manufacturer name and the model number of the sterilization system used
to sterilize the packaging of the product?

c) What is the date of the Process Source of the Package Sterilization System
(mm/dd/yyyy) _ _ / _ _ / _ _ _ _
d) Supplemental Submission Identifier (SUP SID) _ _ _ _ - _ _ - _ _ - _ _ _

b) What is the Process Source of the Package Sterilization System?

(Attach Supplemental Information) (see accompanying instructions)

c) What is the date of the Process Source of the Package Sterilization System
(mm/dd/yyyy) _ _ / _ _ / _ _ _ _

Continue to Section H.

d) Supplemental Submission Identifier (SUP SID) _ _ _ _ - _ _ - _ _ - _ _ _
(Attach Supplemental Information. Provide name or a brief description of
attachment below.) (See accompanying instructions.)

3. Sterilization System
a) What is the Manufacturer name and the model number of the sterilization system used
to sterilize the packaging of the product?
b) What is the Process Source of the Package Sterilization System?

FORM FDA 2541g (12/20)

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Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g)

H. Scheduled Process
In the section below, please do NOT enter decimal points. They are already on the form. No blank spaces are allowed, therefore, enter leading zeros, where necessary.
Col. 1

Col. 2

Col. 3

Col. 4

Col. 5

Col. 6

Col. 7

Col. 8

Col. 9

Process No

Hold
Tube
Section

Inside
Diameter
of Hold
Tube
Section

Hold Tube
Section
Length

Initial
Temperature

Process Time

Temperature
(at exit of final
hold tube
section)

Fo (F18/250)

Maximum
Product
Flow Rate

Number

Number

Inches

Inches

◦Fahrenheit

Seconds

◦Fahrenheit

Minutes

Gal/min

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FORM FDA 2541g (12/20)

(*only for
heating with
control of flow
rate before the
heater)

Page 6 of 8

Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g)

I. Additional Information (Optional)
Other (Attach document. Provide name or a brief description of attachment below.)

Comments:

Note: Under the terms and provisions of Title 18, Section 1001, United States
Code, in any matter within the jurisdiction of the executive branch of the
Government of the United States it is a criminal offense to falsify, conceal, or
cover up a material fact; make any materially false, fictitious, or fraudulent
statement or representation; or make or use any false writing or document
knowing the same to contain any materially false, fictitious, or fraudulent
statement or entry.

when it contains parameters that cannot be reconciled with one another, such
that the filing does not describe a process that could actually be carried out. If
we determine that your process filing appears fabricated, we will delete the
filing from our system and notify you. We will not consider you to have
complied with 21 CFR 108.35(c)(2) until you submit a completed process filing
that does not appear to be fabricated.

If your process filing appears to be fabricated, the product on this form will not
be in compliance with 21 CFR 108.35(c)(2). A process filing appears fabricated
Full Name (Please Type or Print)
Establishment Name

FORM FDA 2541g (12/20)

Signature
State or Province

Country (other than U.S.)

Page 7 of 8

Date

Telephone No.

Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g)

LACF Contact Information
For more information, contact the LACF Registration Coordinator by e-mail at [email protected] or phone: 240-402-2411.
For paper submissions, send completed forms to:
Food and Drug Administration
LACF Registration Coordinator (HFS-303)
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740-3835

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
PAPERWORK REDUCTION ACT NOTICE
The time required to complete this collection of information is estimated to average 45 minutes per response,
including the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any other
aspect of this information collection, including suggestions for reducing this burden, to:
FDA PRA Staff
Office of Operations
Food and Drug Administration
email to [email protected]
“An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 2541g (12/20)

Page 8 of 8